An advisory committee at the U.S. Food and Drug Administration, or FDA, voted 8-6 with one abstention over a two-day hearing Thursday and Friday to recommend that BPC-157 peptide substances, free base and acetate, be placed on the FDA’s 503A bulks list, which would allow their compounding by some pharmacies.
The vote of the Pharmacy Compounding Advisory Committee rejected the recommendation of FDA scientists that BPC-157 “not be included” on the list. The scientists said peptides aren’t well defined and there is limited information about their safety and risks to the immune system as well as insufficient evidence about their effectiveness for ulcerative colitis, which has other FDA-approved therapies.
All eight votes in favor of adding BPC-157 to the list were from committee members recently appointed by U.S. Department Health and Human Services, or HHS, Secretary Robert F. Kennedy Jr.’s FDA, including physicians with conflicts of interest because they sell peptides, a compounding pharmacist, and a pharmacy business executive.
Kennedy is a strong proponent of unproven peptides, which he has used to treat his own injuries and has pledged to end the FDA’s “war” on peptides, Nina Zeldes, Ph.D., health research group researcher for Public Citizen, an advocacy organization, said in a statement.
The committee is expected to vote on six more peptides.
“BPC-157 substances should go through the standard FDA approval process for new drugs and not be added to the 503A bulks list,” Zeldes said. “Adding BPC-157 to the list would set a dangerous regulatory precedent and put patients at risk.”
Robert Steinbrook, M.D., health research group director at Public Citizen, said a stacked FDA advisory committee has delivered for Secretary Kennedy, disregarding the evidence-based conclusion of FDA scientists that BPC-157 peptide substances shouldn’t be placed on the 503A bulks list.
“For its own credibility and to protect public health, the FDA must stand firm, reject the anti-scientific recommendation of an advisory committee rife with conflicts of interest, and not allow the compounding of BPC-157,” Steinbrook said.
The National Consumers League, an advocacy group, urges consumers to follow the advice of the American Medical Association and global health bodies, which urge consumers not to self-inject research-grade synthetic peptides due to the serious safety risks associated with these peptides, including severe immune reactions and possible organ damage.
The peptides haven’t been proven through clinical trials to be safe and are prohibited for human use in Canada, Australia, the European Union, and by the World Anti-Doping Agency, the NCL said in a statement.
Peptides, short strings of amino acids, are the building blocks of proteins naturally produced in the body, and they act as cellular messengers to regulate functions such as metabolism, tissue repair, hormone production and immune responses.
The FDA has approved more than 100 peptide-based drugs, including insulin and GLP-1 medications, to treat conditions ranging from diabetes and metabolic disorders, to osteoporosis, multiple myeloma, and severe chronic pain, based on large-scale human clinical trials demonstrating their safety and effectiveness.
However, thousands of consumers are going to an underground market to buy unapproved, unregulated injectable “wellness” peptides directly from online storefronts, med-spas, and wellness clinics without understanding that these peptides aren’t intended for human use.
